Former Heartburn Drug User Files Suit Against Drug Maker in New Jersey Court

PHILADELPHIA — A New Jersey man filed a putative nationwide class action against the manufacturer of Propulsid in a New Jersey state court Oct. 31, seeking economic damages and medical monitoring to detect early signs of heart disease allegedly caused by the drug (Bernesser v. Johnson & Johnson Corp., N.J. Super. Ct., Middlesex Cnty., No. MID-L-8861-00, complaint filed 10/31/00).

Robert Bernesser sued Johnson & Johnson Corp. and its subsidiary Janssen Pharmaceutical Corp. Bernesser took Propulsid for two years to treat acid reflux. He seeks to represent anyone who took the drug from July 1, 1993, through July 14, 2000. The suit was filed in the New Jersey Superior Court for Middlesex County.

The Food and Drug Administration approved Propulsid for treatment of nighttime heartburn in July 1993. The defendants agreed to withdraw it from the market in August, following reports of dozens of deaths from cardiac arrhythmia or cardiac arrest associated with its use, according to the complaint.

The plaintiff asked the court to certify a medical monitoring subclass and a subclass of all Propulsid users who suffered economic loss as a result of purchasing the drug. The class and subclasses "number in the tens, if not hundreds, of thousands of persons," making it impractical to join all the members of the proposed class in a single action, according to the complaint.

The suit was filed in Middlesex County Superior Court to comply with an order issued Sept. 11 by New Jersey Supreme Court Chief Judge Deborah T. Poritz designating all pending and future Propulsid-related litigation in New Jersey as a mass tort.

The court ordered all such cases to be filed in or transferred to Middlesex County, where Superior Court Judge Marina Corodemus and Special Master Joyce M. Usiskin will oversee all pretrial case management and discovery and decide when the cases are ready for trial "in a venue to be determined."

The order noted that "these cases involve several thousand litigants and complex legal and factual issues and may pose an unnecessary burden on litigants and on judicial resources unless managed equitably, efficiently, and economically."

The four-count complaint states claims for consumer fraud, failure to warn, negligence, and defective design under New Jersey's Consumer Fraud Act and Products Liability Act and common law.

Johnson & Johnson allegedly omitted, concealed, or downplayed facts about the safety and efficacy of Propulsid to secure federal regulatory approval for the drug and increase its sales, according to the complaint. The company failed to conduct adequate clinical testing and post-marketing surveillance to determine the safety of the drug and failed to provide warnings that accurately reflected the symptoms, scope, or severity of its side effects, the complaint alleged.

The plaintiffs are seeking unspecified compensatory damages for economic loss, including the purchase price of the drug, the out-of-pocket cost of interim medical tests and services, and "other costs incidental to [the plaintiffs'] ingestion of a harmful and defective product." Under New Jersey's consumer fraud statute, defendants can be held liable for treble the plaintiffs' actual damages.

The named plaintiff also asked the court to create a medical monitoring trust fund, financed by the defendants, to locate people who used Propulsid and to analyze data for trends of adverse health effects related to Propulsid use. The proposed fund also would provide physicians with information on the diagnosis and treatment of injuries that may result from use of the drug and aid in the early diagnosis and treatment of Propulsid-related injuries through ongoing testing and monitoring of people who used it.

The fund should pay for testing, preventive screening, and care and treatment of heart rhythm abnormalities and/or cardiovascular problems related to Propulsid use, according to the complaint.

The plaintiff also asked the court to award pre- and post-judgment interest and reimbursement for expenses related to the litigation.

The plaintiff is represented by Ridgewood, N.J., attorney Joseph R. Santoli and New York attorney Lee Squitieri of Abbey, Gardy & Squitieri.